The Innovative Medicines Initiative

1
The Innovative Medicines Initiative

• Bologna
• March 27, 2006
• Karen Strandgaard
• EFPIA

2
Objective of the presentation

• Give an overview of the IMI, specifically
• How it started
• What it is
• How will it be implemented

3
RD intensity as of GDP, 2003The EU still has
a way to go to achieve the Lisbon objectives of
3 of GDP
Source European Commission - DG Research, Key
Figures 2005
4
Pharmaceutical RD expenditure in Europe, USA and
Japan (at 2003 constant exchange rates)
27.1

• Declining private investment in RD in Europe
• EFPIA sets the Priority of Strengthening the EU
  Science base
• European Commission is exploring ways to achieve
  the Lisbon objectives
• Innovative Medicines Initiative

21.5
Billion euros
n.a.
2004 figures are estimated Source EFPIA, PhRMA,
JPMA
5
The Innovative Medicines Initiative- A common
European Vision and a Strategic Research Agenda

• The Vision
• Creating biomedical RD leadership for Europe to
  benefit patients and society

6
The Strategic Research Agenda focuses on
bottlenecks in biomedical RD
Efficacy
Safety
7
Efficacy and Safety are often disease
specificFocus initially on four disease areas
with high scientific challenges
Predictive pharmacology
Predictive toxicology
Identification and validation of biomarkers
Patient recruitment
Regulatory Risk assessment
Cancer
Brain Disorders
Inflammatory Diseases
Diabetes
Infectious/ anti-bacterial
8
Applying new technologies to drug discovery a
development requires the active participation of
all stakeholders
Member State policy makers
EU Policy Makers
Research based pharmaceutical Industry
Patients
SMEs
Regulators
Physicians/ healthcare professionals
Academia
Discovery
Preclinical
Translational
Clinical
Pharmaco
research
develop
medicine
development
vigilance
9
SAFETY

• Goal improve the predictability of toxicological
  observations
• Main recommendations
• Create a European Center of Drug Safety
• Establish a framework for biomarker development
  to study human relevance and regulatory utility,
• Develop in silico methods for predicting toxicity
• Optimise data resources and strengthen the
  evidence base in pharmacovigilance
• Develop and strengthen methodologies and networks
  of pharmacovigilance

10
EFFICACY

• Goal improve clinical performance and early
  access to innovative medicine
• Main recommendations
• Stimulate translational medicine in an integrated
  fashion
• Create disease specific imaging networks
• Develop partnership with regulators for
  innovative clinical trial design and acceptance
  of biomarkers

11
KNOWLEDGE MANAGEMENT

• Goal manage and organise data to create
  knowledge to predict benefit and risk of new
  therapies
• Main recommendations
• Develop enhanced knowledge representation models
  and data exchange standards for complex systems,
• Build a core reference database of validated
  experimental data extracted from the literature,
• Design standards for and build an expert tool to
  allow the federation of local databases in a
  secured environment.

12
EDUCATION TRAINING

• Goal Europe should support the interdisciplinary
  education essential to the bioscience sector
• Main recommendations
• Create a European Medicines Research Academy for
  education and training for professionals involved
  in biomedical RD including regulatory officers
  over the whole lifecycle of a medicine,
• Map existing activities within ET including
  identification of European centres of excellence
  and develop programmes and implementation plans
  for the critical areas relevant to the biomedical
  RD process,
• Evaluate options to foster mobility between
  academia and industry.

13
The Innovative Medicines Initiative.

• .. Will
• Improve the way new medicines are created
• Establish Public-Private-Partnerships
• ..Will Not
• Deliver new medicines per se

Enabling the discovery of new medicines for the
benefit of patients
14
Timelines across the European Commissions RD
programmes, FP6 and FP7
2002
2006
FP6
Submission Nov 2004
Funds Oct 2005

• Integrated Project
• Toxicogenomics
• Biomarkers in AD
• Cost 18 mio euros

The Innovative Medicines Initiative
Implementation of the Strategic Research
Agenda Costs 440 mio euros per year
Development of the Strategic Research Agenda
FP7
2013
2007
AD Alzheimers Disease
15
FP6 Integrated Project Innovative Medicines16
Companies 13 Universities 7 SMEs

• Biomarkers in Alzheimers Disease
• 3 large Companies AstraZeneca, GSK, Lilly
• 10 Universities Kings College London,
  University of Kuopio, Perugia, Stockholm,
  Toulouse, Karolinska, Southampton, Thesalonikki,
  Roskilde University, University College London,
• 6 SMEs BioWisdom, Capsant, Cerebricon,
  Pharmidex, Proteome Sciences, Hunter Fleming
• Predictive Toxicology
• 13 large Companies Altana, Bayer,
  Boehringer-Ingelheim, Johnson Johnson, Merck
  AG, Novartis, Novo-Nordisk, Organon, Roche,
  Sanofi-Aventis, Schering, Serono, Servier
• 3 Universities University of Wuerzburg, Dublin,
  and Istanbul
• 1 SME Genedata

16
Proposed Funding Structure Estimated at 440 mio
euros/yearEU funds to academia and SMES,
Industry finances its own participation 100
17
It is an opportunity to regain EU
competitivenessCreating a Win-Win situation for
all stakeholders (1)

• EU and Member States
• Provides a means of gaining competitive advantage
  if we act fast
• Creation of significant economic value through
  small and large enterprises in Europe
• More effective healthcare
• Retain scientific talent and expand science base
• Public and private biomedical community
• Faster drug development process
• Shared risk of implementing new technologies ?
  access to venture capital
• A framework within which academia can bid for
  work in priority areas and establish
  collaborations
• Vibrant and dynamic scientific environment
• Access to pre-competitive knowledge

18
It is an opportunity to regain EU
competitivenessCreating a Win-Win situation for
all stakeholders (2)

• Society / Patients
• More jobs in the EU
• Faster access to innovative therapies such as
  personalized medicines, etc
• Discussion forum on risk assessment of different
  therapeutic classes
• More Education and Training available in the
  biomedical arena

19
Competitive Environment in the World
20
The end
21
Research Directors Group Member Companies
22
Summary

• It is about Patients
• It is about collaboration on scientific advances
• It is possible Pilot project InnoMed started in
  October 2005 (FP6)
• It is supported by a wide community as showed by
  consensus on the Strategic Research Agenda
• It is about establishing new types of PPPs where
  all public money goes to academia and SMEs
• It is an opportunity to regain EU competitiveness
  creating a win-win situation for all stakeholders

23
Experts from different backgrounds contributed to
the Strategic Research Agenda
9
9
3
European Commission
SME
6
Regulatory
Academia
Patient
Pharma
16
34
Others
23
24
Components of the Strategic Research Agenda for
Innovative Medicines

• Analysis of current strengths and weakness in
  Europe
• Recommendations to address bottlenecks
• Definition of the necessary research and
  technical priorities in the medium to long term
• Estimation of resources and timelines
• Principles agreed upon by stakeholders to foster
  productive public/private partnerships

25
Why the selected disease areas?

• High unmet medical need
• Each has distinctive technical challenges
• Strategic Research Agenda for Europe (SRA)
  implementation will lead to real progress within
  the timeframe of the SRA
• Synergies and common themes
• Feasibility in addressing the defined bottlenecks